About deleting, restoring, and viewing deleted form records
Whenever you restore a form record, its data becomes available to modify in a subject's forms again. Moreover, data is marked as restored in several User Interface (UI) areas, such as the Answer & Visit History sidebar or in any applicable reports.
Note:
Do you want to restore any deleted record forms? See Restore deleted forms.Linked form records and predefined rules
- If the deleted form is linked to another question or form, the link isn't restored along with the form. You must create those links again, after restoring the deleted forms. For step-by-step guidelines, see Link forms.
- Even if you add and then delete rows from a repeating form with a label question, and either the Show Section rule is untriggered and re-triggered, or the associated lab is changed, you can still view and restore the previously deleted rows.
- If you delete a repeating form row or a two-section form instance that is associated with an untriggered visit (whether it is a dynamic visit or a Screen Failure, Study Completion, or Withdrawal visit) and the visit is triggered, you can view and restore those deleted records.
- If there is a Show Section predefined rule configured for a two-section form, and the form section isn't displayed yet, the link to the Deleted Forms or Deleted History page isn't available. First, you'd have to trigger the form section to be displayed, and then you can view deleted form records.
Data collection workflows
The following apply to specific data collection workflows, such as uploading documents, or integrating EHR or safety data:
- If your study is integrated with a safety system
and you delete a safety case form flagged as Serious Adverse
Event (SAE), the SAE is canceled. When you restore that SAE
form record, the original safety case is re-opened.
If you restore a form record that should be
associated to a safety case, you may need to manually
re-associate the form record to the safety
case.
Note:
If there are incomplete and required questions in the form you just restored, don't submit the safety case until you enter the required data. If the triggering criteria is no longer met, you shouldn't re-open the safety case. - If a deleted form record contains attached documents, these documents can be viewed on the Deleted Forms page. When you restore a form record with attached documents, these documents are restored, as well.
- When you restore a form record that contains EHR data, the Imported from EHR tag is displayed again, unless you update the data after the form record is restored.
- If you restore a form and a safety case triggering condition is now met, a new safety case won't be opened unless the value is modified after the form was restored. For more information on safety cases, see About collecting adverse event data when integrating with Safety.
Data that is signed and verified, locked, or frozen
- If you delete form records that contain
signed or verified data, the status of all impacted
questions, form records, and associated visits is
updated to either Unsigned,
Unverified, or both. If you restore form records
that were previously Unsigned or Unverified after
you deleted them, their status is preserved as
Unsigned or Unverified.
On the Deleted Forms or Deleted History pages, while the form records remain deleted, you can see the related actions on the Answer & Visit History sidebar. You cannot see any related icons next to the form records, whether the form records are deleted or restored. For example, you won't see icons related to the deleted form records being complete, incomplete, signed, or verified.
Data that is frozen or locked
- You cannot delete a form row or instance that is locked. If a form is locked after any of its records are deleted, you cannot restore the removed records, even if you can view them on the Deleted Forms or Deleted History pages. In the case of a repeating form, if all rows were deleted and the visit is locked, at least one question in the visit should be unlocked so that you can restore the deleted repeating form row. If at least one instance of a form is not locked, you can restore the deleted records.
- You can still view a deleted form record
that's locked, but you cannot restore it.
If you must restore form records that are currently locked, work with your Clinical Research Associate (CRA) to unlock any required form records.
- You can still restore deleted form records, even if the form is frozen. For example, if you previously deleted Record 1 and Record 2 of Repeating Form A, these deleted form records are deleted and not frozen. After you deleted Record 1 and Record 2, another sponsor user freezes the entire Repeating Form A. You can still restore deleted Records 1 and 2, despite the entire form being frozen. The form records you restore aren't frozen automatically, another sponsor user should freeze them after you restore the form records.
- If you restore deleted form records for a visit that is frozen, the visit's status remains as Frozen after the records have been restored. The restored form records will remain editable. If you restore a form record that was previously unfrozen, and you edit its data, it will not automatically refreeze.
- If a form record is unlocked or unfrozen before you delete it, its status (Unfrozen and Unlocked) is displayed in the Answer & Visit History sidebar.
- If you restore a record that was previously unlocked, unsigned, unverified, or unfrozen, their corresponding icon won't show up next to the question.
Related Topics
Parent topic: Enter data and dispense kits